Efficacy, Safety, and Tolerability of Tirzepatide in Real-World Conditions in Paraguay.

Sponsor
Las Rías Medical Center
Study ID
NCT07588438
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide (LIPOLESS de Laboratorio de Productos Eticos C.E.I.S.A.) — DRUG
    Participants will receive subcutaneous injections of tirzepatide (LIPOLESS de Laboratorio de Productos Eticos C.E.I.S.A.) once weekly. The dosage will be adjusted according to standard clinical practice and the investigator's discretion, following the manufacturer's titration schedule (starting at 2.5 mg and increasing up to 15 mg as tolerated).

Study Details

This is a prospective cohort study evaluating the efficacy, safety, and tolerability of tirzepatide under real-world conditions in the Paraguayan population. The study includes two cohorts: Cohort 1 consists of adults with obesity (BMI ≥30 kg/m²) without type 2 diabetes mellitus (T2DM), and Cohort 2 consists of adults with T2DM with or without obesity. Each cohort will enroll 80 participants (160 total). All participants will receive tirzepatide as part of their standard clinical care and will be followed for 52 weeks with visits approximately every 6 weeks. Primary outcomes include percentage change in body weight from baseline at week 52 (Cohort 1) and change in HbA1c and body weight at week 52 (Cohort 2). Safety outcomes include adverse event rates. The study is conducted at Las Rias Medical Center, Asuncion, Paraguay, and has been approved by the CEI-INCAN Ethics Committee and authorized by DINAVISA.

Key Dates

First listed
May 14, 2026
Start date
Jul 27, 2026
Status verified
May 2026
Primary completion
Aug 10, 2027
Completion
Aug 10, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Obesity Without T2DM
    Adults with obesity (BMI ≥30 kg/m²) without type 2 diabetes mellitus, receiving tirzepatide as part of standard clinical care.
  • Experimental: Cohort 2: T2DM With or Without Obesity
    Adults with type 2 diabetes mellitus (with or without obesity), receiving tirzepatide as part of standard clinical care.

Primary Outcome Measure

Mean Percent Change From Baseline in Body Weight at 52 Weeks. [ Time Frame: Baseline and 52 weeks. ]

Central Contacts

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